Method for forming a catheter having overlapping welds

ABSTRACT

In a method of forming a catheter having an inner layer, an intermediate braided layer and an outer jacket, wherein the intermediate braided layer terminates axially before the inner layer, leaving a forward end portion of the inner layer exposed, the steps of: 
     a) before applying the outer jacket, loading a plastic sleeve over a forward end of the intermediate braided layer adjacent the forward end portion of the inner layer; 
     b) heating the plastic sleeve to a temperature sufficient to melt the plastic sleeve; 
     c) loading a terminal tip having an axial length over a forward end portion of the inner layer into abutting relationship with the forward end of the intermediate braided layer such that the terminal tip is supported by the forward end portion of the inner layer along all of the axial length of the terminal tip and not reinforced anywhere along the axial length by the intermediate braided layer; 
     d) loading the outer jacket over the braided layer; 
     e) loading a shrink tube over the outer jacket; and 
     f) heating to cause the shrink tube to compress the outer jacket into the interstices of the intermediate braided layer.

RELATED APPLICATIONS

This is a continuation of application Ser. No. 08/673,563 filed Jul. 1,1996, now abandoned, which is a continuation-in-part of Ser. No.08/596,759 filed Feb. 5, 1996, now abandoned, which is acontinuation-in-part of Ser. No. 08/570,941 filed Dec. 12, 1995, nowU.S. Pat. No. 5,772,641 issued Jun. 30, 1998.

TECHNICAL FIELD

This invention relates generally to catheter constructions, and moreparticularly to welded joints between adjacent lengths of cathetermaterial, as well as a related method of manufacturing such catheters.

BACKGROUND AND SUMMARY OF THE INVENTION

Currently, both diagnostic and therapeutic catheters are manufactured byforming braided tubes of stainless steel fibers or strands, over amandrel. More specifically, the braided tube may be formed about aninner Teflon® liner or tube initially carried on a supporting mandrel.An outer plastic layer may then be extruded about the braided materialto create the catheter body. Current catheter constructions also utilizea transition tip which is not reinforced with braid in order that thetip be softer and more flexible than the remaining portions of thecatheter. In some catheter designs, an even more flexible tip (alsoreferred to as the terminal tip) is bonded to the free end of thetubular transition tip.

Catheters which incorporate multiple axial sections typically employbutt or lap weld joints to secure the axial sections of the cathetertogether. See, for example, U.S. Pat. Nos. 5,254,107; 4,861,337;4,793,351; 4,662,404; and 4,391,302. Some catheter constructions utilizea tapered joint where the terminal tip is joined to the catheter body.See, for example, U.S. Pat. Nos. 4,886,506 and 4,385,635.

Catheters incorporating either butt or lap type welded joints are notcompletely satisfactory however, and it is thus the object of thisinvention to improve upon prior catheter constructions by incorporatingunique weld configurations which have a substantial axial seam componentextending along the axis of the catheter. In other words, adjacentcatheter sections (and not including the terminal tip) are cut andwelded in such a way that they overlap in the longitudinal direction,but without altering the outer diameter of the catheter. Thisarrangement not only increases surface area at the weld joints andthereby also increases bond integrity, but also creates a more desirabletransition between the same materials of different durometer ordifferent materials with or without the same durometer, than other moreconventional welds such as lap or butt welds.

The unique weld configurations of this invention also permit alterationof properties or characteristics of the catheter material in the area ofthe weld, and this feature is particularly advantageous in areas of thecatheter that will be curved, in that different stiffness or hardnessmaterials can be used on the inside and outside portions of the curve.

Examples of the unique weld configurations in accordance with thisinvention include step joints, taper joints, and combinations of thetwo.

This invention also relates to an improved method for manufacturingbraid reinforced catheters with or without the unique axial weld jointsas described above. In the exemplary embodiment, the process relates tothe manufacture of a catheter having inner and outer layers sandwichedabout a braided tube layer. The inner layer is preferably formed fromTeflon® while the outer layer is provided in the l form of three axialjacket sections, one of which comprises nylon and the others of whichcomprise a polyether block amid (PEBA), such as that commerciallyavailable under the name Pebax®.

In the process, a thin walled Teflon® tube is loaded onto a stainlesssteel mandrel. In a separate operation, a spring temper stainless steelwire is braided onto a disposable (preferably plastic) mandrel at aspecified braid density and with a diameter approximating the diameterof the Teflon® covered mandrel described above. Predetermined lengths ofthe braided stock are cut and the disposable mandrel is removed anddiscarded. One end of the braided wire tube is then placed in anannealing fixture so that about a 1/2 inch long section of the braidedtube is annealed. The annealed section is then trimmed to leaveapproximately a 1/16 inch long section of annealed braid.

Starting with the non-annealed end of the braided tube, the latter isloaded onto the Teflon® covered mandrel, sliding the annealed sectionover the end of the Teflon® tube so that approximately 1 inch of theTeflon® tube is left exposed. It is desirable to anchor the annealedsection of the wire braid to the Teflon® tube, and this is done using avariety of methods including bonding the annealed wire section to theTeflon® using adhesives. In accordance with the present process,however, the annealed end portion of the wire braid is anchored to theTeflon® base using a sleeve of PEBA material or, preferably, a hightemperature polyester ester material applied with the assistance of ashrink film or tube such as FEP-Teflon. The compressive force generatedby the shrink film, combined with the heat inherent in the process ofshrinking the film, cause the PEBA or the polyester ester sleeve to meltinto the interstices of the wire braid at the same time that the wiresare being forced flat against the inner Teflon® layer. This results inthe annealed wires being held neatly in place so that they will not bedisturbed during the remainder of the catheter assembly process.

In the next process step, a 1/2 inch length of soft terminal tip stockmaterial is threaded over the end of the Teflon®/mandrel assembly sothat it comes into contact with the end of the annealed portion of thewire braid described above. To keep the terminal tip in place, a tightpress fitted piece of Teflon® tubing may be threaded onto theTeflon®/mandrel assembly and advanced until it is butted up against thetip stock. This so-called "bumper" will keep the tip stock in placeduring the remainder of the catheter process, and will also keep theterminal tip material from flowing out of the end of the assembly duringthe thermal processing which follows.

As mentioned above, the outer layer of the catheter consists of threedifferent extruded sections of tubing which have specific wallthicknesses and inside diameters which are no smaller than the outsidediameter of the wire braid. The primary jacket is formed from nylon 12with 30% BASO₄, and it is approximately 80 cm. in length and forms themain shaft with the catheter. The secondary jacket is PEBA with a ShoreD durometer of 70, and again with 30% BASO₄. This secondary jacket isapproximately 25 cm. in length. A tertiary jacket is formed from a softPEBA, with a Shore D durometer of 48 also with 30% BASO₄. This tertiaryjacket is approximately 7 cm. in length and generally forms the softprimary curved section of the catheter. It should be noted, however,that PEBA could be substituted in part or all for the nylon 12, and theBASO₄ could consist of more or less than 30%, and other radio paqueagents such as but not limited to bismuth subcarbonate and the like maybe employed. The axial jackets are cut such that they can be joinedusing the axial seam weld constructions described above.

The tertiary jacket is first loaded onto the end of the braided tube andTeflon® inner layer assembly, opposite the end with the annealed sectionof wire braid and moved axially along the mandrel until it contacts theterminal tip stock. The secondary jacket is then loaded onto theassembly with its weld seam oriented as necessary to the correspondingweld seam of the tertiary jacket. The primary jacket is then loaded inthe same fashion.

A second FEP shrink tube is loaded over the entire catheter assembly,and the assembly is then placed into an oven or other heated chamberwhere the FEP shrink tube is heated, causing the now molten jackets tocompress into the interstices of the wire braid, contacting and adheringto the etched surface of the Teflon® liner. The use of the hightemperature polyester ester sleeve mentioned above for anchoring thebraid end wires is particularly advantageous in that this material doesnot re-melt in the second heat shrink operation, thus substantiallyeliminating any possibility of freeing the braid end wires. After theassembly has cooled to room temperature, the second FEP shrink tube andthen the stainless steel mandrel are removed. Finally, the soft terminaltip stock can be cut to the desired length and any of a variety of knownmethods can be utilized to "reflow" the cut end of the tip such that thesoft PEBA material flows beyond the end of the Teflon® liner, leavingthe liner encapsulated by a small tip of PEBA material.

In its broader aspects, the present invention provides in a method offorming a catheter having an inner layer, an intermediate braided layerand an outer jacket, wherein the intermediate braided layer terminatesaxially before the inner layer, leaving a forward end portion of theinner layer exposed, an improvement including the steps of:

a) before applying the outer jacket, loading a plastic sleeve over aforward end of the intermediate braided layer adjacent the forward endportion of the inner layer; and

b) heating the plastic sleeve to a temperature sufficient to melt theplastic sleeve.

In still another aspect, the present invention provides in a method offorming a catheter, an improvement including the steps of:

a) loading an inner liner on a mandrel;

b) loading a braided tube over the inner liner such that a predeterminedlength of the inner liner adjacent one end of the braided tube is leftexposed;

c) loading a plastic sleeve over the one end of the braided tube;

d) loading a shrink tube over the plastic sleeve;

e) heating the shrink tube, causing the plastic sleeve to melt intointerstices of the braided tube at the one end; and

f) removing the shrink tube.

Other objects and advantages of the subject invention will becomeapparent from the detailed description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation, partly broken away, of a conventionalcatheter construction;

FIG. 2 is a side section of the distal end of the catheter shown in FIG.1;

FIG. 3 is a section taken along the line 3--3 of FIG. 2;

FIG. 4 is a cross section of a conventional lap weld in a catheter;

FIG. 4A is a partial side section of the welded joint illustrated inFIG. 4;

FIG. 5 is a side elevation of a catheter incorporating a step weld inaccordance with the present invention;

FIG. 5A is a section taken along the line 5A--5A of FIG. 5;

FIG. 6 is a side elevation of a catheter incorporating a multi-step weldin accordance with the invention;

FIG. 7 is a side elevation of a catheter incorporating a shallow angleweld in accordance with the invention;

FIG. 8 is a side elevation of a catheter incorporating a steep angleweld in accordance with the invention;

FIG. 9 is a side elevation of a catheter incorporating a combinationstep/angle weld in accordance with the invention;

FIG. 10 is a side elevation of a catheter incorporating a combinationstep, angle and butt weld in accordance with the present invention;

FIG. 11 is a partial side elevation illustrating a catheter withmultiple sections including a curved section incorporating a weld inaccordance with the subject invention;

FIG. 12 is a partial side elevation of a catheter in accordance with theinvention;

FIG. 13 is a partial side elevation illustrating the manner in which theend of a wire reinforcement braid is secured to an inner layer of acatheter during the manufacturing process;

FIG. 14 is a partial side elevation illustrating the manner in which aterminal tip is added to the forward end of the catheter during themanufacturing process;

FIG. 15 is a side elevation of an assembled catheter in accordance withthe process of this invention, prior to thermal processing; and

FIG. 16 is a schematic side elevation illustrating the catheter of FIG.15, covered with a shrink tube, ready for thermal processing.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 represent a known catheter construction of the typedisclosed in U.S. Pat. No. 5,254,107. The catheter assembly 10 includesa conventional hub 12 at its proximal end, and a tubular catheter 14extending from the hub 12 to a distal end 16. The catheter may have afirst axial section 18, a second axial section 20 and a distal tipsection 22.

The catheter 14 comprises an inner tubular plastic layer 24, which maybe made of fluoro polymers such as PTFE, FEP or other similar polymers.A second layer 26 comprises a braided stainless steel tube applied by aconventional braiding machine. An outer, third layer 28 of plastic isthen applied by suitable means over the braided layer. As disclosed inthe '107 patent, this outer layer may include two or more axialsections. For example, the first axial section 18 may be made of aplastic material such as nylon 12 with a Shore D durometer of 65-70. Thesecond axial section 20 may be nylon 12, and may have a Shore Ddurometer of 35-45. The transition tip 22 may be made of polyurethanewith a Shore A durometer of about 80. In the '107 patent, the adjacentaxial sections are butt welded or fused together, such that the jointsdescribe circles C1 and C2 perpendicular to the longitudinal axis of thecatheter.

The present invention relates to new and unique weld configurations forjoining axial sections of the outer plastic layer of a catheter asgenerally described above.

Conventional welds used in catheter constructions are either of the butttype shown in FIGS. 1 and 2, or of the overlapping variety, typicallyknown as "lap" welds as shown in FIGS. 4 and 4A (inner layer and braidedlayer removed for the sake of clarity). Thus, one tubular portion 30 isreceived over a second tubular portion 32 and welded thereto, such that,in the weld area, a double thickness is created, as best seen in FIG.4A.

In accordance with this invention, welds are used to connect lengths ofcatheter tubing, which welds are designed to have substantial axiallength, but without altering the outer diameter of the catheter. In FIG.5, for example, a first catheter length 34 is connected to a secondcatheter length 36 by a step weld 38 which includes radial seam portions40 and 42 and extended axial seam portions 44, 44A (see FIG. 4A). Notethere is no double thickness of material and no change in outsidediameter. Here again, internal layers have been omitted simply for thesake of clarity.

In FIG. 6, a multi-step weld 46 axially joins catheter lengths 48 and50, with the weld having three radial seam portions 52, 54 and 56 andtwo extended axial seam portions 58 and 60.

In FIG. 7, a shallow angle weld 62 axially joins catheter lengths 64 and66. While no purely radial weld seam portions are formed in thisarrangement, a single extended axial portion 68 gradually transitionsalong a shallow angle ∝.

FIG. 8 illustrates a variation in the weld configuration of FIG. 7, inthat the weld 70 axially joining catheter lengths 72, 74 axially along aseam 76 which makes a relatively steep angle β.

FIG. 9 illustrates a hybrid weld 78 axially joining catheter lengths 80,82 along a pair of angled seams 84, 86 connected by an extended axialseam 88.

FIG. 10 illustrates yet another hybrid weld 90 axially joining catheterlengths 92, 94. The weld includes a radial seam portion 96 and an angledseam portion 98 connected by an extended axial seam portion 100.

In each instance, the above described welds axially join two lengths ofcatheter with a significant axial seam portion (at least about 0.5 cm.in axial length and preferably 0.5-10 cm.) but without altering theoutside diameter (OD) of the catheter. In other words, the OD of theouter plastic layer does not change and, in no case are there doublethicknesses as in lap welds. At the same time, unlike butt welds, theweld seams extend axially along the length of the catheter. Theseextended axial portions of the various weld configurations (thelongitudinal or axial extent of which may be varied) allow the catheterto be constructed with certain desired properties or characteristics asexplained below.

The overall increased surface area of the welded joints increases thebond integrity between the two joined sections. The various weldconfigurations also create more desirable transitions between materialsof different durometers, resins, etc. than typical butt or lap weldedjoints.

It is also possible to vary the characteristics of the catheter alongits length by means of the overlapping welds described herein. Forexample, for the catheter shown in FIGS. 5 and 5A, with an axiallyextended overlap of from, e.g., 0.5 to 10 cm., a unique section ofcatheter is created where section 34 might be a hard durometer (e.g.,60-70 on the Shore D Scale) and section 36 a soft durometer (e.g., 25-50Shore D Scale or even a very soft Shore A hardness), the combined axialsection along the axial length of the weld has a stiffness which is theaverage of the two durometers. This ability to create lengths ofcatheter with different properties or characteristics is mostadvantageous in areas of the catheter which will incorporate (or be bentinto) curved areas.

With reference now to FIG. 11, which illustrates the catheter sections34 and 36 in a curved state through the weld area 38, the length 34 hasa harder durometer--on the outside of the curve; while the length 36 hasa softer durometer--on the inside of the curve. As a result, not onlydoes the weld overlap area have a desirable stiffness which fallsbetween the stiffness of the materials used to form sections 34 and 36,but in addition, unique curve retention properties are created by reasonof the dominance of the harder durometer over the softer durometer. Thisis merely one example of the many possible applications of the concept.It is quite possible, for example, that for a similar curved area with adifferent purpose, the softer durometer may be on the outside and theharder durometer on the inside of the curve. By altering the radiallocation of the axial seam of the weld, different percentages of harderand softer durometers can be employed. As a visual aid to distinguishcatheter sections having different properties, the axially overlappingsections may be color coded.

It should also be pointed out that the different catheter lengths can beof the same material (e.g., suitable resins) but have differentdurometers, or they can be of different materials of the same ordifferent durometer. Suitable resins include Nylon 11 and Nylon 12;Pebaxe (25D to 70D); Nylon/Pebax® blends; polyurethanes (largedurometer-infinite range); polyethylenes (high and low density); PVC;and other medical grade resins and various combinations of same.

Typical catheter constructions as shown and described herein may be inthe size range of 1-15 French (0.013" to about 0.200" I.D.).

One or more inner layers (omitted from FIG. 5A but similar to FIG. 3)may include, for example, a conventional PTFE, FEP or similar linerreinforced by stainless steel braid. The invention here is applicable,however, to a wide range of catheter types. For example, both diagnostic(angiography) and therapeutic (guiding) catheters (and other cathetertechnologies such as PTA, PTCA, electrophysiology, pacing leads, etc.)are suitable candidates for incorporation of the welds of thisinvention. Such catheters, as indicated above, may or may not includewoven or braided reinforcements. Such reinforcements, if used, maycomprise metal or synthetic materials including stainless steel,Kevlar®, etc. The catheters may be of single or multi-lumen design andmay or may not have a Teflon® or other friction reducing lining. Thecatheters may or may not have a tapered distal portion and may or maynot have side ports. While the catheter constructions illustrated hereinshow only a single weld per catheter, i.e., two axial sections, itshould be understood that each catheter may have more than one weldedarea and may incorporate two or more different resins with the same orvarying durometers.

With regard to the weld areas per se, the transition portions, i.e., theaxially extending portions of the weld, may have an axial length toradial depth ratio of from about 3:1 to about 40:1. For purposes ofdiscussion herein, a short transition weld has a ratio of about 3:1 toabout 12:1, whereas a long transition weld has a ratio of about 12:1 toabout 40:1. Short transition welds provide increased surface areas whichstrengthens the welded joints, and provide longer, less abrupttransition areas than simple butt welds. Such welds minimize thetendency of kinking and provide better torque transmissioncharacteristics than conventional butt welds.

Long transition welds also provide increased surface area forstrengthening the welded joints. In addition, long transition weldsproduce more desirable feel and/or handling characteristics in use. Theorientation of different materials in long transition welds providesease of straightening and permits unique properties to be establishedwithin one or more curved areas of the catheter. Long transition weldsalso allow for greater differences in durometer.

A preferred process for manufacturing catheters as generally describedabove will now be explained in detail. For purposes of explaining theprocess, a preferred catheter construction is shown at 110 in FIG. 12.The catheter includes three axial sections: a primary section 112, asecondary section 114, and a tertiary transition tip section 116. Aterminal tip 118 is also secured at the distal end of the catheter. Thecatheter also includes an inner layer 120, preferably of Teflon®, and astainless steel braid layer 122 sandwiched between the inner Teflon®layer 120 and the outer layer comprising jacket sections 112, 114 and116 (see FIG. 13).

Initially, the thin walled, highly lubricious inner Teflon® layer 120 inthin tubular form, is loaded onto a generally rigid, preferably solid,ground stainless steel mandrel 124 of approximately 44" in length. Thelayer 120 may have a wall thickness of about 0.0015", and the exteriorsurface thereof is etched.

Separately, ultra spring temper stainless steel wire is braided onto acontinuous length of a disposable (preferably plastic) mandrel (notshown). The braid density is approximately 60-PIC, and the mandrel has adiameter which approximates the diameter of the Teflon® covered mandreldescribed above. The braided stock is cut to a length of approximately44", and the disposable mandrel then removed. One end of the cut braidedtube or layer 122 is placed into an annealing fixture and, afterannealing about a 1/2 inch section of the braided tube, the annealedsection is cut so as to leave an annealed end of approximately 1/16" inlength at one end of the braided tube 122.

Now, starting with its non-annealed end, the braided tube 122 is loadedonto the Teflon® covered mandrel, finally sliding the annealed end overthe end of the mandrel 124 so that about 1 inch of Teflon® is leftexposed (see FIG. 13). In other words, the 1/16" annealed end of thebraided tube 122 lies adjacent a 1 inch exposed end of the Teflon® layer120. It has been found that by annealing the end of the braided tube,the cut ends thereof will lie flat, in a relaxed state, on the Teflonlayer 120. Otherwise, the cut ends would tend to spring outwardly andnot only inhibit loading of the axial jacket sections, but alsopotentially damage the latter as well.

In order to facilitate loading of the axial jacket sections over theintermediate braided tube layer 122, it has also been found desirable toanchor the end of the wire braid layer or tube 122 to the Teflon® layer120 to further facilitate loading the axial jacket sections. In apreferred arrangement in accordance with the process of this invention,the annealed end of the wire braid layer or tube 122 is anchored to theinner Teflon® layer 120 using a small, thin walled (0.002 inch) sleeve126 of PEBA material. After the sleeve 126 is loaded onto the annealedend of the braided tube as shown in FIG. 13, a first shrink film or tube128 is applied over the sleeve. The shrink film, which may be formed ofFEP-Teflon®, is then heated to 385°-400° F. so that the compressiveforce during shrinking, combined with the heat inherent in the process,causes the PEBA sleeve 126 to melt into the interstices of the braidedlayer 122, at the same time that the cut end wires are being forced flatagainst the Teflon® layer 120. This results in the end wires being heldneatly in place so that they will not be disturbed during the remainderof the assembly process.

With reference now to FIG. 14, a length of soft tip material (which maybe a softer PEBA material, e.g., a Shore D of about 30), in the form ofa sleeve 130, is threaded over the end of the Teflon® inner layer sothat it is in abutting contact with the annealed end of the braid layeras described above. In order to keep the tip sleeve 130 in place, aTeflon® tube 132 may be press fit over the Teflon® inner layer andadvanced until it butts up against the tip sleeve 130. This bumper willkeep the tip in place during the remainder of the catheter processing,and will keep the tip material from flowing out of the forward end ofthe assembly during the remaining thermal processing described below.

The first or primary jacket section 112 (comprising the major lengthportion of the catheter) is formed in the exemplary embodiment fromNylon 12 with 30% BASO₄. This first axial section may have a length ofapproximately 80 cm. and forms the main shaft of the catheter. Thesecondary jacket 114 is formed from PEBA with a Shore D durometer of 70and approximately 30% BASO₄. This secondary jacket has an axial lengthof about 25 cm. and forms what may be referred to as the Aortic curvesection of the catheter. The tertiary jacket 116 is formed from a softPEBA with a Shore D durometer of 48 and approximately 30% BASO₄. Thistertiary jacket may have a length of about 7 cm. and forms the softprimary curve section of the catheter, also known as the transition tip.

The jacket sections 112, 114 and 116 are cut axially and loaded into thebraided assembly (inner layer 120 and braid layer 122) as follows.

First, the tertiary jacket 116 is loaded onto the end of the braidedassembly opposite the end with the annealed section of wire braid. Thistertiary section 116 is moved along the braid layer 26 until it fullycovers the annealed section of the braid, and contacts the tip stocksleeve 130. The secondary jacket 114 is then loaded onto the braidedassembly such that the weld seams are aligned (as shown, for example, inFIGS. 5-10 depending on the specific weld or combinations of weldsused). The primary jacket section 112 is then loaded onto the braidassembly in the same fashion.

With the axial three jacket sections 112, 114 and 116 loaded onto thebraided assembly, and with the weld type joints properly oriented, asecond length of FEP shrink tube 134 (see FIG. 15) of approximately 44inches in length is placed over the entire catheter assembly, includingthe tip stock sleeve 130. The shrink tube used is usually a 1.4:1 to1.6:1 shrink ratio, with dimensions that may differ depending on thesize of the catheter being made. The catheter assembly 136 is thenplaced into an oven 138 (FIG. 16) or onto a conveyor which passesthrough a heated chamber. Using the appropriate time and temperaturecriteria (again, the temperature is 385°-400° F.), the FEP tube 134 isshrunk, causing the now molten primary, secondary and tertiary jackets112, 114 and 116 to compress into the interstices of the braid layer122, and thus also contact and adhere to the etched surface of theTeflon® layer 120 as well.

After the assembly has cooled to room temperature, the FEP shrink tube134 is slit or perforated and peeled off the assembly, and the bumper132 removed. The stainless steel mandrel 124 is then removed from theinternal diameter of the assembly.

The terminal tip sleeve 130 is then cut to a desired length(approximately 2 mm) and then, using any of a variety of conventionalmethods, reflowed such that the soft PEBA material flows beyond the endof the PTFE liner. As a result, the end of the PTFE liner 24 isencapsulated by the small terminal tip 118 of PEBA material (see FIG.12), thus forming the terminal tip. This soft tip 118 will overlie theone inch exposed portion of the Teflon® layer 120 but it will not haveany wire braid reinforcement.

The end result is a catheter shaft which has multiple durometersections, continuous ultra spring stainless steel wire extending up tothe soft tip, and a continuous Teflon® liner extending through the tip.The catheter also contains the unique axially disposed welded sectionsas described earlier, imparting different properties to the catheter atthe desired axial locations thereof, and particularly in the curvedareas.

In accordance with this continuation-in-part application, it has nowbeen discovered that the thin wall sleeve 126 utilized to hold the cutend wires of the braid layer 122 against the Teflon® layer 120, ispreferably formed of a high temperature thermoplastic material such aspolyester ester. One such material is that available under the tradename ARNITEL, available from Dutch State Mines (DSM). After thepolyester ester sleeve 126 is loaded on the annealed end of the braidedtube, the shrink film or tube 128 is again applied over the sleeve.While typically, the temperature utilized in the heat shrinking step isgauged to the shrink tube properties, the temperature is raised to themelting temperature of the polyester ester (about 425° F.) in order tocause the sleeve to melt into the interstices of the braided layer 122.Except for the somewhat higher temperature, this step is essentially thesame as explained hereinabove. The subsequent heat shrink step,(utilizing the second FEP shrink tube 134) carried out after the threeaxial jacket sections 112, 114 and 116 have been loaded onto the braidedassembly, is carried out as described hereinabove, and at the sametemperature. Because, however, the polyester ester material has a highermelting temperature than the previously described PEBA material, thepolyester ester does not remelt during this second heat shrink step. Ithas been found that the use of polyester ester for the sleeve 126 ismore effective in holding the end wires of the braid in place, flatagainst the Teflon® layer 120. By not remelting the polyester ester, thepossibility of the braided wire ends becoming free and possiblyprotruding into the outer jacket is substantially eliminated.

While the above process has been described in connection with a catheterhaving three discrete exterior axially oriented jacket sections, it isalso possible to create a coextruded tube which contains differentdurometers and/or different material compositions in varying ratios atspecific points along the tube, creating a gradual controllable changein section. For example, it is possible to have a coextruded tube whichcontains a generally stiff material such as, but not limited to, nylon12 and a considerably softer material such as, but not limited to, aPebax® 55D. The tube may have a wall thickness of 0.008 inches. The mainlength of the tube, which could represent the shaft of the catheter,would have a 0.008 inch wall which has a 7:1 ratio of nylon to Pebax®55D, respectively. At the specific point along the length of the tube,this ratio would be varied at a desired rate until the desired ratio ofnylon to Pebax® 55D is achieved, at say, about 1:7. In this way, it ispossible to form a monolithic tube with a constant wall thickness thathas variable stiffness along its length. This monolithic tube could thenbecome the jacket for the assembly in the process as otherwise describedabove.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

What is claimed is:
 1. In a method of forming a catheter having an innerlayer, an intermediate braided layer and an outer jacket, wherein theintermediate braided layer terminates axially before the inner layer,leaving a forward end portion of the inner layer exposed, the stepsof:a) before applying the outer jacket, loading a plastic sleeve over aforward end of the intermediate braided layer adjacent the forward endportion of the inner layer; and b) loading a first shrink tube over theplastic sleeve and heating the shrink tube to a temperature sufficientto melt the plastic sleeve; c) removing the first shrink tube; d)loading a terminal tip having an axial length over the forward endportion of the inner layer, into abutting relationship with the forwardend of the intermediate braided layer such that the terminal tip issupported by said forward end portion of said inner layer along all ofsaid axial length of said terminal tip and not reinforced anywhere alongsaid axial length by said intermediate braided layer; e) loading theouter jacket over said intermediate braided layer into abutting contactwith said terminal tip; f) loading a second shrink tube over the outerjacket and the terminal tip; and g) heating the second shrink tube tocause the second shrink tube to compress the outer jacket and to causethe outer jacket to melt into interstices of the intermediate braidedlayer and contact the inner layer.
 2. The method of claim 1 wherein theplastic sleeve is composed of a polyester ester material.
 3. The methodof claim 1 wherein said inner layer and said intermediate braided layerare loaded onto a mandrel prior to step a).
 4. The method of claim 1wherein, during step g), the plastic sleeve is not remelted.
 5. Themethod of claim 1 wherein prior to step a), the forward end of theintermediate braided layer is annealed.
 6. The method of claim 1 whereinstep e) comprises loading a plurality of outer jacket sections in axialalignment.
 7. In a method of forming a catheter, the steps of:a) loadingan inner liner on a mandrel; b) loading a braided tube over the innerliner such that a length of the inner liner adjacent one end of thebraided tube is left exposed forming an exposed length having an endportion; c) loading a plastic sleeve over said one end of the braidedtube; d) loading a first shrink tube over the plastic sleeve; e) heatingthe first shrink tube, causing the plastic sleeve to melt intointerstices of the braided tube at said one end; f) removing the firstshrink tube; g) loading a terminal tip sleeve having an axial lengthdirectly over said exposed length of the inner liner, into abuttingrelationship with said one end of the braided tube, such that theterminal tip sleeve is not reinforced anywhere along said axial lengthby said braided tube and such that said terminal tip sleeve is supportedby said exposed length of said inner liner along all of said axiallength; h) loading an external jacket over the braided tube to therebyform a catheter assembly, the external jacket in abutting relationshipwith the terminal tip sleeve; i) applying a second shrink tube over theexternal jacket and said terminal tip sleeve; j) heating the catheterassembly to cause the second shrink tube to compress and the externaljacket to melt into the interstices of the braided tube and contact theinner liner; and k) cooling the catheter assembly and removing thesecond shrink tube and the mandrel.
 8. The method of claim 7 wherein theplastic sleeve is composed of a polyester ester material.
 9. The methodof claim 7 wherein, during step j), the plastic sleeve is not remelted.10. The method of claim 7 wherein, prior to step b), said one end ofsaid braided tube is annealed.
 11. The method of claim 7, furthercomprising:l) cutting said terminal tip sleeve to a desired length; andm) causing said terminal tip sleeve to flow beyond said end portion ofsaid exposed length of said inner liner to thereby encapsulate said endportion of said exposed length of said inner liner and form a terminaltip on said end portion of said exposed length of said inner liner.